b'BRIEF SUMMARY OF PRESCRIBING INFORMATIONDimensions: 15.75 x 10.75 BELSOMRA (suvorexant) tablets, for oral use, C-IVINDICATIONS AND USAGE ADVERSE REACTIONSBELSOMRA is preferred and available at theBELSOMRA is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleepThe following serious adverse reactions are discussed in greater detail in other sections:maintenance. It is not known if BELSOMRA is safe and effective in children under the age of 18. CNS Depressant Effects and Daytime Impairment [see Warnings and Precautions]Lowest Branded Co-pay Tier, with restrictionDOSAGE AND ADMINISTRATION Worsening of Depression/Suicidal Ideation [see Warnings and Precautions]Dosing Information Complex Sleep Behaviors [see Warnings and Precautions]on TRICARE Uniform Formulary. RestrictionUse the lowest dose effective for the patient. For all BELSOMRA doses, take no more than once per night within 30Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, Cataplexy-Like Symptoms [see Warnings andminutes of going to bed (with at least 7 hours remaining prior to planned awakening). Time to effect of BELSOMRA mayPrecautions]is a prior authorization.be delayed if taken with or soon after a meal. Patients with Compromised Respiratory Function [see Warnings and Precautions] The recommended dose for BELSOMRA is 10 mg, taken no more than once per night. If the 10 mg dose is well-toleratedClinical Trials Experiencebut not effective, the dose can be increased. The maximum recommended dose of BELSOMRA is 20 mg taken no moreBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the than once per night. clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect Special Populations the rates observed in clinical practice.Co-pay* Exposure to BELSOMRA is increased in obese compared to non-obese patients, and in women compared to men.In 3-month controlled efficacy trials (Study 1 and Study 2), 1263 patients were exposed to BELSOMRA including Delivery Method Supply Particularly in obese women, the increased risk of exposure-related adverse effects should be considered before493 patients who received BELSOMRA 15 mg or 20 mg (see Table 1). Active Duty Non-Active Duty increasing the dose.In a long-term study, additional patients (n=521) were treated with BELSOMRA at higher than recommended Military Treatment Facility $0 $0 Check local formulary Use with CNS Depressants doses, including a total of 160 patients who received BELSOMRA for at least one year.When BELSOMRA is combined with other CNS depressant drugs, dosage reduction of BELSOMRA and/or Table 1: Mail $0 $34 Up to 3 months the other drug(s) may be necessary because of potentially additive effects [see Warnings and Precautions]. Patient Exposure to BELSOMRA 15 mg or 20 mg in Study 1 and Study 2Dosage Adjustments with CYP3A InhibitorsRetail $0 $38 Up to 1 month When used with moderate CYP3A inhibitors, the recommended dosage of BELSOMRA is 5 mg taken no more than oncePatients Treated BELSOMRABELSOMRA per night (the dose generally should not exceed 10 mg). BELSOMRA is not recommended for use with strong CYP3A15 mg 20 mginhibitors [see Drug Interactions]. For1 Day (n) 202 291Sources: Formulary data provided by Fingertip Formulary, April 2022; Express Scripts Federal Pharmacy Services. TRICARE Formulary Search Tool, May 2022. CONTRAINDICATIONSMen (n) 69 105BELSOMRA is contraindicated in patients with narcolepsy.Women (n) 133 186Lowest Branded Co-pay Tier means product is available on the lowestFormulary status is believed to be accurate at the time of printing and/orWARNINGS AND PRECAUTIONSMean Age (years) 70 45co-pay tier designated by the plan for branded products. Plan bene t designdistribution but cannot be guaranteed. Formulary status for national plansCNS Depressant Effects and Daytime Impairment For3 Months (n) 118 172may place branded products in a lower tier (ie, generics tier) and patients maymay not re ect plan variation at the local level.BELSOMRA is a central nervous system (CNS) depressant that can impair daytime wakefulness even when used as prescribed. Prescribers should monitor for somnolence and CNS depressant effects, but impairment can occur in have a lower cost-sharing amount for such branded products. the absence of symptoms, and may not be reliably detected by ordinary clinical exam (i.e., less than formal testingThe pooled safety data described below (see Table 2) reflect the adverse reaction profile during the first Updated formulary status information for Medicare plans may be available3 months of treatment.*Co-pay range is for the selected plan and geography. Patient co-pay canfrom the Centers for Medicare & Medicaid Services: www.medicare.govof daytime wakefulness and/or psychomotor performance). CNS depressant effects may persist in some patients vary depending on a patients speci c prescription coverage and plan bene tfor up to several days after discontinuing BELSOMRA. Adverse Reactions Resulting in Discontinuation of TreatmentUpdated TRICARE formulary status information may be available atBELSOMRA can impair driving skills and may increase the risk of falling asleep while driving. Discontinue or decreaseThe incidence of discontinuation due to adverse reactions for patients treated with 15 mg or 20 mg of BELSOMRA design. Patient may have a deductible or other cost-sharing amounts thatwww.express-scripts.com/frontend/open-enrollment/tricare/fst/# the dose in patients who drive if daytime somnolence develops. In a study of healthy adults, driving ability waswas 3% compared to 5% for placebo. No individual adverse reaction led to discontinuation at an incidence 1%.a ect the patients actual out-of-pocket costs. The co-pay range displayedimpaired in some individuals taking 20 mg BELSOMRA. Although pharmacodynamic tolerance or adaptation to someMost Common Adverse Reactionsdoes not include information regarding co-pays applicable to Medicare Part Dadverse depressant effects of BELSOMRA may develop with daily use, patients using the 20 mg dose of BELSOMRAIn clinical trials of patients with insomnia treated with BELSOMRA 15 mg or 20 mg, the most common adverse Low Income Subsidy individuals.should be cautioned against next-day driving and other activities requiring full mental alertness. Patients taking lowerreaction (reported in 5% or more of patients treated with BELSOMRA and at least twice the placebo rate) was doses of BELSOMRA should also be cautioned about the potential for driving impairment because there is individualsomnolence (BELSOMRA 7%; placebo 3%).variation in sensitivity to BELSOMRA. Table 2 shows the percentage of patients with adverse reactions during the first three months of treatment, based Co-administration with other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol) Indication increases the risk of CNS depression. Patients should be advised not to consume alcohol in combination withon the pooled data from 3-month controlled efficacy trials (Study 1 and Study 2).hypnotic-nave as well as hypnotic-experienced persons. Patients usuallyBELSOMRA because of additive effects [see Drug Interactions]. Dosage adjustments of BELSOMRA and ofAt doses of 15 or 20 mg, the incidence of somnolence was higher in females (8%) than in males (3%). Of the BELSOMRA(suvorexant) is indicated for the treatment of insomniaadverse reactions reported in Table 2, the following occurred in women at an incidence of at least twice that in characterized by diculties with sleep onset and/or sleep maintenance. do not remember these events. Complex sleep behaviors may occurconcomitant CNS depressants may be necessary when administered together because of potentially additivemen: headache, abnormal dreams, dry mouth, cough, and upper respiratory tract infection.following therst or any subsequent use of BELSOMRA, with or withouteffects. The use of BELSOMRA with other drugs to treat insomnia is not recommended [see Dosage and The adverse reaction profile in elderly patients was generally consistent with non-elderly patients. The adverse Selected Safety Information the concomitant use of alcohol and other CNS depressants. DiscontinueAdministration]. reactions reported during long-term treatment up to 1 year were generally consistent with those observed during BELSOMRA immediately if a patient experiences a complex sleep behavior.The risk of next-day impairment, including impaired driving, is increased if BELSOMRA is taken with less than athe first 3 months of treatment. BELSOMRA is contraindicated in patients with narcolepsy. full night of sleep remaining, if a higher than the recommended dose is taken, if co-administered with other CNSSleep paralysis, hypnagogic/hypnopompic hallucinations, and cataplexy-likedepressants, or if co-administered with other drugs that increase blood levels of BELSOMRA. Patients should beTable 2: BELSOMRA contains suvorexant, a Schedule IV controlled substance. symptoms can occur. The risk of cataplexy-like symptoms increases with thecautioned against driving and other activities requiring complete mental alertness if BELSOMRA is taken in thesePercentage of Patients with Adverse Reactions Incidence 2% and Greater than PlaceboBELSOMRA can impair daytime wakefulness. Central nervous system (CNS)dose of BELSOMRA. circumstances. in 3-Month Controlled Efficacy Trials (Study 1 and Study 2) depressant e ects can last for up to several days after discontinuation. Because BELSOMRA can cause drowsiness, patients, particularly the elderly, are at higher risk of falls. PlaceboBELSOMRAThe e Worsening of Depression/Suicidal Ideation ect of BELSOMRA on respiratory function should be considered. BELSOMRA can impair driving skills and may increase the risk of fallingReevaluate patients for comorbid conditions if insomnia persists after 7 toIn clinical studies, a dose-dependent increase in suicidal ideation was observed in patients taking BELSOMRA(20 mg in non-elderly or15 mg in elderly patients) asleep while driving.Caution patients taking BELSOMRA 20 mg against next- 10 days of treatment. as assessed by questionnaire. Immediately evaluate patients with suicidal ideation or any new behavioral sign orn=767 n=493day driving and other activities requiring full mental alertness.BELSOMRA is not recommended for patients with severe hepaticsymptom.Gastrointestinal Disorders Coadministration with other CNS depressants increases the risk ofimpairment or those taking a strong CYP3A inhibitor. In primarily depressed patients treated with sedative-hypnotics, worsening of depression, and suicidal thoughtsDiarrhea12CNS depression. Patients should be advised not to consume alcohol inand actions (including completed suicides) have been reported. Suicidal tendencies may be present in suchDry mouth 1 2combination with BELSOMRA due to additive e ects. Dosage adjustments of In pivotal clinical studies, the most common adverse reaction (reported inpatients and protective measures may be required. Intentional overdose is more common in this group of patients;Infections and InfestationsBELSOMRA and of other concomitant CNS depressants may be necessarytherefore, the lowest number of tablets that is feasible should be prescribed for the patient at any one time. 5% or more of patients treated with 15 mg or 20 mg of BELSOMRA and atUpper respiratory tract infection 1 2when administered together because of potentially additive e ects. The useleast twice the placebo rate) was somnolence (BELSOMRA 7%, placebo 3%). The emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation. Nervous System Disorders Complex Sleep Behaviors Headache67of BELSOMRA with other drugs to treat insomnia is not recommended.In the insomnia study in patients with mild to moderate Alzheimers diseaseComplex sleep behaviors, including sleep-walking, sleep-driving, and engaging in other activities while not fullySomnolence37The risk of next-day impairment, including impaired driving, is increasedreceiving BELSOMRA, the adverse reactions occurring 2% and greater thanawake (e.g., preparing and eating food, making phone calls, having sex), have been reported to occur with the useDizziness2 3placebo were somnolence (4% compared to 1% placebo), dry mouth (2%of hypnotics such as BELSOMRA. These events can occur in hypnotic-nave as well as in hypnotic-experiencedPsychiatric Disorders if BELSOMRA is taken with less than a full night of sleep remaining, if acompared to 1% placebo), and falls (2% compared to 0% placebo).persons. Patients usually do not remember these events. Complex sleep behaviors may occur following the firstAbnormal dreams 1 2higher than recommended dose is taken, if coadministered with other or any subsequent use of BELSOMRA, with or without the concomitant use of alcohol and other CNS depressants CNS depressants, or if coadministered with other drugs that increase Available data from postmarketing reports with BELSOMRA use in pregnantRespiratory, Thoracic and Mediastinal Disorders blood levels of BELSOMRA. Patients should be cautioned against drivingwomen are insucient to establish a drug-associated risk of major birth[see Drug Interactions]. Discontinue BELSOMRA immediately if a patient experiences a complex sleep behavior. Cough 1 2and other activities requiring complete mental alertness if taken in thesedefects, miscarriage or adverse maternal or fetal outcomes. Sleep Paralysis, Hypnagogic/Hypnopompic Hallucinations, Cataplexy-Like Symptomscircumstances.Sleep paralysis, an inability to move or speak for up to several minutes during sleep-wake transitions, andDose Relationship for Adverse Reactions There are no data on the presence of suvorexant in human milk, the e ectshypnagogic/hypnopompic hallucinations, including vivid and disturbing perceptions by the patient, can occur There is evidence of a dose relationship for many of the adverse reactions associated with BELSOMRA(suvorexant)Because BELSOMRA can increase drowsiness, patients, particularly theon the breastfed infant or the e ects on milk production. Infants exposed towith the use of BELSOMRA. Prescribers should explain the nature of these events to patients when prescribinguse, particularly for certain CNS adverse reactions.elderly, are at a higher risk of falls. BELSOMRA through breastmilk should be monitored for excessive sedation.BELSOMRA.In a placebo-controlled crossover study (Study 3), non-elderly adult patients were treated for up to one month with The bene ts of breastfeeding should be considered along with the mothersSymptoms similar to mild cataplexy can occur, with risk increasing with the dose of BELSOMRA. Such symptomsIn clinical studies, a dose-dependent increase in suicidal ideation wascan include periods of leg weakness lasting from seconds to a few minutes, can occur both at night and during theBELSOMRA at doses of 10 mg, 20 mg, 40 mg (2 times the maximum recommended dose) or 80 mg (4 times the observed in patients taking BELSOMRA, as assessed by questionnaire.clinical need for BELSOMRA and any potential adverse e ects on theday, and may not be associated with an identified triggering event (e.g., laughter or surprise). maximum recommended dose). In patients treated with BELSOMRA 10 mg (n=62), the types of adverse reactions breastfed infant. observed were similar to those observed in patients treated with BELSOMRA 20 mg. BELSOMRA was associated with Immediately evaluate patients with suicidal ideation or any new onsetPatients with Compromised Respiratory Function a dose-related increase in somnolence: 2% at the 10 mg dose, 5% at the 20 mg dose, 12% at the 40 mg dose, and behavioral changes. Suicidal tendencies may be present and intentional The recommended dose of BELSOMRA is 5 mg in patients receivingEffect of BELSOMRA on respiratory function should be considered if prescribed to patients with compromised11% at the 80 mg dose, compared to 1% for placebo. BELSOMRA was also associated with a dose-related increaseoverdose is more common in this group of patients; therefore, the lowestmoderate CYP3A inhibitors. respiratory function. BELSOMRA has not been studied in patients with severe obstructive sleep apnea (OSA) orin serum cholesterol: 1 mg/dL at the 10 mg dose, 2 mg/dL at the 20 mg dose, 3 mg/dL at the 40 mg dose, andnumber of tablets that is feasible should be prescribed for the patient at any Digoxin levels should be monitored, as slight increases were seen withsevere chronic obstructive pulmonary disease (COPD) [see Use in Specific Populations]. 6 mg/dL at the 80 mg dose after 4 weeks of treatment, compared to a 4 mg/dL decrease for placebo.one time. Need to Evaluate for Co-morbid Diagnoses Insomnia Study in Patients with Mild to Moderate Alzheimers Diseasecoadministration of BELSOMRA. Complex sleep behaviors, including sleep-walking, sleep-driving, andBecause sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder,In a 4-week insomnia study of BELSOMRA in 285 patients (BELSOMRA n=142; placebo n=143) with mild to Please see the adjacent Brief Summary of the Prescribing Information.treatment of insomnia should be initiated only after careful evaluation of the patient. The failure of insomnia tomoderate Alzheimers Disease, the adverse reactions occurring 2% and greater than placebo were somnolence engaging in other activities while not fully awake (eg, preparing and eating remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that(4% compared to 1% for placebo), dry mouth (2% compared to 1% for placebo), and falls (2% compared to 0% for food, making phone calls, having sex), have been reported to occur withshould be evaluated. Worsening of insomnia or the emergence of new cognitive or behavioral abnormalities mayplacebo).the use of hypnotics such as BELSOMRA. These events can occur in be the result of an unrecognized underlying psychiatric or physical disorder and can emerge during the course ofPost-Marketing Experiencetreatment with hypnotic drugs such as BELSOMRA. The following adverse reactions have been identified during post-approval use of BELSOMRA. Because these Copyright2022 Merck & Co., Inc., Rahway, NJ, USA and its aliates. All rights reserved.US-IMA-01985 09/22belsomra.com'